Day 1

Day 2
Resources

Please find the session links next to their corresponding agenda item.

Prerecorded

Overview of FDA and Regulatory Processes
Steven S. Tjoe, Senior Associate, Goodwin Procter LLP

Watch this session here.

Please find the session links next to their corresponding agenda item.

Wednesday, March 16

11:00 AM 

FDLI Welcome and Announcements
Khara L. Minter, Assistant Director, Training Programs, FDLI

Enter this session: https://fdli.zoom.us/j/88914451347

11:05 AM– 12:20 PM 

Introduction to FDA Review and Approval of Biological Products
Catherine M. Cook, Principal for Regulatory Policy, Greenleaf Health, Inc.

Enter this session: https://fdli.zoom.us/j/88914451347

12:20 – 12:30 PM 

Break

12:30 – 1:45 PM 

Regulation of Biological/Product Development
Christopher M. Mikson, Partner, DLA Piper LLP

Enter this session: https://fdli.zoom.us/j/88370110809

1:45 – 1:55 PM

Break

1:55 – 3:10 PM

Human Cellular and Tissue Based Products (HCT/P), Cell Therapy and Gene Therapy
Gail Javitt, Partner, Hyman, Phelps & McNamara, PC

Enter this session: https://fdli.zoom.us/j/84151333402

3:10 – 3:20 PM

Break

3:20 – 4:35 PM

Biological Product Approval, Vaccines, Emergency Use Authorization
Christina M. Markus, Partner, King & Spalding LLP
Eva Temkin, Partner, King & Spalding LLP

Enter this session: https://fdli.zoom.us/j/87663960692

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